FDA Approves Drug to Ease Symptoms of Opioid Withdrawal

The FDA approved the first non-opioid drug, lofexidine hydrochloride (Lucemyra), to help treat symptoms of opioid withdrawal in adults.

Thus far, patients with OUD have managed withdrawal by. Lucemyra is similar to clonidine, which FDA staff had noted in discussing the drug with an advisory committee in March, is often used off-label for opioid withdrawal symptoms. Clinical investigations will be required to assess the wellbeing of Lucemyra in clinical circumstances where utilize could be relied upon to surpass the most extreme 14-day treatment period for which the item is as of now affirmed, for example, steady opioid decrease; to accumulate extra security information on the impacts of lofexidine on the liver; and to additionally describe the consequences for circulatory strain after lofexidine is halted. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA.

Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions. It is approved for treatment for only up to 14 days.

In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid.

The drug has not been evaluated in people under age 17, the FDA said.

Lucemyra is an oral, specific alpha 2-adrenergic receptor agonist that decreases the arrival of norepinephrine.

The most common side effects of the drug include low blood pressure, a slower than normal heart rate, sleepiness, and dizziness. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent. Some patients received Lucemyra, and some patients received a placebo. Lucemyra was also associated with a few cases of syncope (fainting).

The FDA is requiring 15 post-marketing studies - or studies that happen after a drug is approved. Additional animal safety studies will be required to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children. Studies in pediatric patients will include studies of newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs.

Lofexidine had fast-track designation and was reviewed under the FDA's priority review process.

Because Lucemyra will be available without the restrictions surrounding drugs like buprenorphine or methadone, patients potentially will be able to get it from their family doctor, Pirner told Insider.